Regulatory Intelligence and Analytics Expert
hace 2 semanas
Company Overview:
PrimeVigilance Ltd, a specialized mid-size pharmacovigilance service provider established in 2008, is proud to have achieved global organic growth year after year.
We are part of Ergomed Group, with staff based across Europe, North America, and Asia covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
As a leading provider of first-class support to pharmaceutical and biotechnology partners, we maintain long-lasting relationships and have become one of the global leaders in our field, covering all therapy areas including medical devices.
Salary:
$80,000 - $110,000 per annum, depending on experience
Job Description:
The Senior Associate/Specialist, Regulatory Intelligence and Analytics will be responsible for completing regulatory deliverables based on an established regulatory plan.
This role serves as a liaison between regulatory and other functional areas, including external partners, clients, authorities, and/or consultants, in the planning, organizing, and preparing of regulatory deliverables following project, corporate, and industry regulatory strategies.
Key Responsibilities:
- Provide intelligence on requirements and contribute to the development of strategy and set up activities, including Regulatory Management Plan, joint operating procedures, POAs, and core documents.
- Support identification of issues.
- Perform regular screening of regulatory legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
- Provide internal teams with guidance on national requirements.
- Ensure compliance with company procedures, processes, training records, systems, and any other tools.
- Promptly identify and escalate risk/potential risk to the project team which may jeopardize deliverables.
- Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
- Provide administrative support to BD activities.
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
- Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
- Provide feedback on performance of vendors to aid their assessment.
Required Skills and Qualifications:
- Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.
- Previous regulatory experience within the pharmaceutical/CRO industry.
Benefits:
We value employee experience, well-being, and mental health and acknowledge that a healthy work-life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Join us in this exciting journey to make a positive impact in patients' lives.
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